The National Agency for Food and Drug Administration and Control (NAFDAC) is alerting the public that Canadian-based Fresenius Medical Care (FMC), manufacturer of Sodium Chloride Injection 0.9% USP, 1000mL had recalled 3 lots of the product due to life threatening leakages in the solution bags.

Sodium Chloride Injection 0.9% USP, is indicated as a source of water and electrolytes for fluid replenishment as required by the clinical condition of the patient and is labelled for IV use as a single dose. Unused portions should be discarded. It is also used as a priming solution in haemodialysis procedures.

Possible associated risks

Leakage of intravenous solution bags may result in a breach of sterility, microbial contamination, or air embolism from air introduced to the IV system. If used in IV admixtures, there is potential for delivery of a more concentrated drug solution than intended.

Healthcare providers in possession of the affected lots of the products should immediately stop their distribution and use; and return them to the nearest NAFDAC office for appropriate regulatory action.

Healthcare providers and patients should report adverse reactions associated with the use of these product to the nearest NAFDAC office, NAFDAC PRASCOR 920543 TOLL FREE from all networks) or via pharmacovigilance@nafdac.gov.ng

Bob is a Senior Editor and Content Development Manager at Nigerian Law Intellectual Property Watch. He holds a BS degree, with a major in biochemistry. He works directly with the Newsroom Team. His focus areas are technology and innovation, and pharmaceutical technology. Email: baroture@nlipw.com

Related Articles

Early this week, the House of Representatives stopped the consideration of the N18.9bn 2017 budget of the National Agency for Food and Drug Administration and Control (NAFDAC), which has passed its first and second readings. […]

One of the main requirements for applying to the National Agency for Food and Drug Administration and Control (NAFDAC) for permission to introduce your products into the Nigerian market is to submit copies of your […]

Last week, NAFDAC Director on Special Duties, Dr. Abubakar Jimoh affirmed the circulation of fake malaria tablet in Nigeria and urged health care providers and other members of the public to be on alert for […]

The World Trade Organization (WTO), World Health Organization (WHO) and World Intellectual Property Organization (WIPO) will on February 26, 2018, convene a symposium to discuss challenges and opportunities to ensure that innovative technologies are developed in order [...]